Job Description:
Require engineer experience of break down & trouble shooting, routine repairs and maintenance activities of all Formulation equipment's.
Required experience of vial & ampoule line equipment's of injectable facility, handling maintenance of machines like Vial washing, Vial Filling & sealing machine, Rotary washing, Filling & Sealing, Dry Powder Line, inspection & Packing machines autoclave,
Perform breakdown maintenance, corrective maintenance, electrical maintenance, mechanical maintenance, and preventive maintenance on equipment such as injectables, sterile machines, etc.
Conduct routine checks to identify potential issues before they become major problems.
Troubleshoot and resolve technical issues related to plant operations.
Collaborate with other teams to optimize production processes and improve overall efficiency.
Ensure compliance with safety protocols and quality standards.
Documentation knowledge like DQ, IQ, OQ.
Robust understanding of breakdown analysis, breakdown maintenance, engine design principles, and predictive/preventative maintenance techniques.
Familiarity with GMP regulations (USFDA), ISO standards (ISO 9001), ICH guidelines (ICH Q3D), BPR review process.

📌 Officer Regulatory Affairs Surat (India)
🏢 SDP HR Solution
📍 India